Information about Military and Civilian Biodefense/Terrorism Countermeasures, vaccines, laws and policies

August 27, 2007

Inhaled anthrax vaccine promising in early studies

NEW YORK (Reuters Health) - An experimental anthrax vaccine that is administered intranasally, rather than by intramuscular injection, can protect against exposure to lethal amounts of Bacillus anthracis, the bacteria that causes anthrax, the results of an animal study show.

The anthrax vaccine currently in use, which was developed over 30 years ago, requires multiple injections and is associated with various side effects. This limits the usefulness of this vaccine in response to emergencies, such as a biological attack with the microbe, researchers point out in the journal Infection and Immunity.

Dr. James R. Baker, from the University of Michigan in Ann Arbor, and colleagues describe the development and testing of a new intranasally administered anthrax vaccine in mice and guinea pigs.

The vaccine consists of a B. anthracis protein that triggers immune protection. This is mixed in a nontoxic water-in-oil nanoemulsion that serves as an "adjuvant," an agent that improves the effectiveness of a vaccine or treatment. This adjuvant enhances penetration of the mucus membranes in the nasal passages to deliver more of the active portion of the vaccine, and avoids the inflammatory side effects seen with the older vaccine.

The researchers found that the experimental vaccine induced bronchial and blood antibodies against B. anthracis in mice and guinea pigs. Further analysis indicated high blood levels of neutralizing antibodies against the anthrax toxin.

The vaccinated guinea pigs were protected against B. anthracis exposure, while all of the unvaccinated animals died within 96 hours of exposure, the report indicates.

The immunity provided by the vaccine appeared to be long lasting as well. In comments to Reuters Health, Baker noted that the "animals were protected for 6 months after second administration" of the vaccine.

He added that "studies need to be performed in humans to confirm the findings" and that these "should begin within a year."

The fatality rates of anthrax are based on the route of transmission, which may be through an opening on the skin, such as a cut (cutaneous); through ingestion, if the bacteria contaminate food; or by inhalation.

Anthrax fatality rates also vary depending on whether the patient receives treatment, which may be successful if started early; but most patients aren't diagnosed until the infection is more advanced.

The mortality rates for untreated and treated infections range from 1 percent to 20 percent for cutaneous transmission and 25 percent to 60 percent for gastrointestinal transmission, respectively. However, the fatality rate for inhalation anthrax is very high -- 75 percent -- with or without treatment.

Symptoms include flu-like symptoms, fever, cough, sore throat, and a sore on the skin that starts as a bump and develops into a painless ulcer with a black area in the center.

As biodefense research booms, reward is weighed against risk

Ellen Vitetta is a chairwoman at the Cancer Immunobiology Center at UT Southwestern Medical Center in Dallas. Her research centers on ricin, a potentially lethal toxin that paradoxically may have benefits as a vaccine to fight cancer.

But her work interested the federal government for different reasons.

In the aftermath of the anthrax attacks in October 2001, bioterrorism was seen as more than just an idle threat.

The drumbeat for more biodefense spending as part of the war on terror resulted in passage of Project BioShield in 2004, which appropriated $6 billion for research over 10 years.

"If I had put in for a federal grant for ricin vaccine pre-9-11, it would have come back in a garbage pail," Vitetta said.

But because ricin is a potential biological weapon, UT Southwestern received a federal grant to continue its research -- with a dual purpose.

While she is somewhat dismayed that her work has been co-opted in the name of national security, Vitetta is hopeful that in the long run a ricin vaccine will help win the war on cancer as well as the war on terror.

"We'll use the money to learn as much as we can," she said, "and be poised to use vaccines [in a way] that are more useful to the American public."

Biological and chemical warfare may be as old as conflict itself, but before anthrax-laced letters infected 22 people, resulting in five deaths, research in the U.S. had been almost exclusively the domain of the military.

Now, some estimate that more than 400 university laboratories alone are involved in biodefense research, up from a handful just a decade ago.

Many research labs work with infectious agents such as Ebola, anthrax, West Nile virus, Q fever, tularemia and avian flu, as well as emerging drug-resistant forms of tuberculosis. Others work with more garden-variety organisms.

"Everyone and their cousins are trying to get into it because it's where the money is and it's necessary," said Ronald Blanck, former president of the University of North Texas Health Science Center, who previously served as the U.S. Army surgeon general and commander of the Army's medical branch during a 32-year military career.

He says that even though the focus is on biodefense, the expanded research will eventually benefit public health.

"The work being done is beginning to leverage against threats from naturally occurring diseases like avian flu," he says. "A lot of the infrastructure for biological-weapons research is also preparing us to deal with things like a flu epidemic."

But there is grumbling in the scientific community among researchers who feel that they have been "drafted" into working on national defense.

And watchdog organizations say that the facilities conducting research have proliferated to extremes, increasing the risk of accidents or security breaches and making oversight more difficult for federal agencies.

Edward Hammond, director of the Sunshine Project in Austin, says that government oversight is not stringent enough, that laboratory security is suspect and that accidents sometimes go unreported, or worse, are covered up.

"Ultimately we don't need 400 institutions across the U.S. working on biological-weapons agents," Hammond said. "We've gone way overboard. I request records from universities, and there are wildly divergent interpretations of what constitutes security.

"They're all doing it by the seat of their pants."

Ronald Kendall, director of the Institute of Environmental and Human Health at Texas Tech University, defends the escalation in biodefense spending, saying, "When we [Tech] got into it in 1998, there was a national consortium of just four universities. It might be debated whether we are overreacting ... but the consensus of 16 intelligence agencies is that there is a high level of threat from an attack.

"If we don't prepare ourselves, the consequences could be devastating."

But Hammond -- who does not argue with the need for biodefense research, only the scope of it -- says the popular notion that an international terrorist will smuggle biological weapons into the U.S. is not nearly as likely as an accident or a nefarious act by a rogue scientist, which may have occurred in the 2001 anthrax attacks. The crimes have not been solved.

"The greatest threat is not going to be a guy in a turban but in our own biochemical labs," Hammond said.

Incidents at Texas A&M

Are Hammond's allegations the rhetoric of an overzealous, self-appointed public whistle-blower? Or does he have a valid case?

In July, the Centers for Disease Control and Prevention temporarily suspended work at Texas A&M's Level 3 biosafety lab for failing to report two separate incidents in which workers became ill working with infectious agents. Probing by the Sunshine Project brought the violations to light.

Three lab workers were infected with Q fever and one other with the agent Brucella. None of the cases was fatal, and none of those infected spread the diseases.

The CDC investigation has since found other violations of federal regulations at the College Station lab, and, early this month, the vice president who oversees biodefense research at A&M stepped down. The university chancellor has repudiated the lab's actions.

The revelations created a public relations nightmare for biodefense advocates.

"We're not at all pleased to learn that this happened," said Stanley Lemon, principal investigator for the University of Texas Medical Branch in Galveston, which has a BSL-4 lab, dealing with the highest-risk agents such as Ebola, for which there are no treatments or preventives.

"We try to be as faithful as possible to the laws. It is complicated because different agencies are involved, but I'm very comfortable with the level of security here."

Kendall of Texas Tech, which has a BSL-3 lab, called the incident "unfortunate," adding, "It's a barometer of society that when an organization or university makes a mistake, we're all lumped together."

Ironically, if ramping up fear among Americans about the threat of biological warfare was intended, in part, to drum up public support for biodefense spending -- as some conspiracy buffs theorize -- then the downside is that accidents may result in an overreaction by the public and in the media.

Gigi Kwik Gronvall, a senior associate at the Center for Biosecurity at University of Pittsburgh Medical Center, knows firsthand how public opinion can scuttle a growth industry. Her father worked at a nuclear power plant.

The nuclear-power industry suffered a catastrophic blow in the U.S. after an accident at Three Mile Island in Pennsylvania in 1979 produced a partial meltdown.

Although the danger of an explosion was remote, and inspections at the time and in the months afterward did not turn up abnormal radiation in the atmosphere, public confidence in nuclear energy waned.

Biodefense research may not be strictly analogous, but some of the same apprehensions are in play.

Proponents say the research being done in containment labs is not a significant risk to the public.

"Research labs work with relatively small amounts of agents, which are not weaponized, and only certain people have access to them," said Rona Hirschberg, a microbiologist and senior program officer for the National Institute of Allergy and Infectious Diseases. "I can't say there is no risk to the public at large, but the real danger in a lab is to the people who work there."

The Texas Tech institute, which does some work with ricin and screens for West Nile virus, has strict safeguards in place, said Steve Presley, a research coordinator involved with the program.

"We have three layers of secure access to the labs," he said, "and any agent or toxin at high risk is under locked access."

At UT Southwestern, Vitetta said there are significant amounts of ricin in the BSL-3 lab.

Security was one of the issues on the agenda a year ago when Gronvall of the University of Pittsburgh led a meeting of biodefense experts from around the country.

One recommendation from that meeting was to always keep the community informed and reassured.

The UT Medical Branch and the Texas Tech institute have advisory boards composed of people in the community, part of the effort to be more accountable to the public.

UTMB even lists accidents in its containment labs on its Web site.

BSL labs were not always so forthcoming. Credit for this type of disclosure has been given to the Sunshine Project, which uses open records requests to scrutinize laboratory practices and put pressure on the labs to be more forthcoming.

"It's about the right to know," Hammond said.

A strict system

Vitetta acquiesced to stepped-up security measures and the intrusion into her personal life imposed by the federal government when the emphasis of her ricin research shifted to biodefense.

Key codes and passwords are required to gain access to the lab and the bioagents.

Personnel are subject to background checks, and the FBI fingerprints them. There are site checks by the CDC.

"But there are no secret handshakes," she said.

"The system, though, is only as good as the people who work in the labs. We spend a lot of time with how things can be circumvented or sabotaged," Vitetta said. "My life is consumed with compliance."

At Texas Tech, the doors to the institute lock automatically at 5 p.m., said Kendall, the director. "We have a very sophisticated system. It's expensive, and it would take a pretty intense effort to get in.

"We know we can't afford to make mistakes relevant to exposure" even though the amounts of the materials involved are often small, Kendall said. "The stakes are high, and we have enormous public support."

This is not a Hollywood disaster movie in the making, the researchers say. Even if a terrorist were to gain access to a laboratory, finding an infectious agent would be difficult.

"There is no vial in a refrigerator labeled 'avian flu,'" said Lemon of UTMB.

Labs typically use only small quantities, and a great deal of scientific expertise would be needed to weaponize the bioagents.

Nonetheless, the recent events at Texas A&M will keep the biodefense industry under a microscope, and there is no way of knowing the ramifications as the CDC continues its investigation.

Research in bioterror and biomedicine is conducted in hundreds of laboratories at U.S. universities and centers. The biosafety research labs are classified by the type of organisms used and the risk posed to personnel. The Centers for Disease Control and Prevention stipulates standards for each level of laboratory and the degree of protection required for personnel, the environment and the community. Rona Hirschberg, a microbiologist and senior program officer for the National Institute of Allergy and Infectious Diseases, describes each level:

BSL-4

Work is with the most dangerous organisms and viruses as well as with some related viruses for which there are no effective vaccines or treatments. There is considerable risk to people working in these laboratories if they don't follow precautions. The staff must have training in handling extremely hazardous infectious agents and must understand the primary and secondary containment functions of standard and special practices, containment equipment, and laboratory design. Access is limited and controlled by the laboratory supervisor.

Work with dangerous organisms, particularly those transmitted through the air. In some cases, there are vaccines or effective treatments available. Laboratory personnel must receive specific training in handling pathogenic and potentially lethal agents and must be supervised by scientists competent in handling infectious agents and associated procedures.

Work involves agents that cause human disease but pose only a minor risk and are not transmitted through the air. Access to the lab is restricted when work is being conducted; all procedures in which infectious aerosols or splashes may be created are conducted in designated physical containment equipment.

Type of agents: Staph, strep, salmonella, garden-variety influenza.

Texas sites: University and medical labs

BSL-1

Basically teaching labs found on most university campuses, and organisms do not cause human disease. Work involves well-characterized agents not known to consistently cause disease in healthy adult humans and presents minimal potential hazard to laboratory personnel and the environment. Special containment equipment or facility design is not required but may be used as determined by appropriate risk assessment. Basic precautions are still followed.

Type of agents: Soil bacteria and bacteria commonly found in food such as dairy products.

Texas sites: University and medical labs

Sources: Centers for Disease Control and Prevention, www.cdc.gov; National Institute of Allergy and Infectious Diseases, www3.niaid.nih.gov; Sunshine Project

August 20, 2007

US reporters must reveal sources in Anthrax suit

Five reporters must reveal their government sources for stories they wrote about Steven J Hatfill and investigators' suspicions that the former Army scientist was behind the deadly anthrax attacks of 2001, a federal judge has ruled.

According to a report in the Washington Post, the ruling is a victory for Hatfill, a bioterrorism expert who has argued in a civil suit that the government violated his privacy rights and ruined his chances at a job by unfairly leaking information about the probe. He has not been charged in the attacks that killed five people and sickened 17 others, and he has denied wrongdoing. Reporters believe the Hatfill case probably will have ‘horrifying’ repercussions on the ability to report on the government's handling of public health crises.Full report in The Washington Post (See Aug. 14th archives)

August 19, 2007

Homeland Security Enlists Clergy to Quell Public Unrest if Martial Law Ever Declared

http://www.ksla.com/Global/story.asp?S=6937987

Could martial law ever become a reality in America? Some fear any nuclear, biological or chemical attack on U.S. soil might trigger just that. KSLA News 12 has discovered that the clergy would help the government with potentially their biggest problem: Us.

Charleton Heston's now-famous speech before the National Rifle Association at a convention back in 2000 will forever be remembered as a stirring moment for all 2nd Amendment advocates. At the end of his remarks, Heston held up his antique rifle and told the crowd in his Moses-like voice, "over my cold, dead hands."

While Heston, then serving as the NRA President, made those remarks in response to calls for more gun control laws at the time, those words live on. Heston's declaration captured a truly American value: An over-arching desire to protect our freedoms.

But gun confiscation is exactly what happened during the state of emergency following Hurricane Katrina in New Orleans, along with forced relocation. U.S. Troops also arrived, something far easier to do now, thanks to last year's elimination of the 1878 Posse Comitatus act, which had forbid regular U.S. Army troops from policing on American soil.

If martial law were enacted here at home, like depicted in the movie "The Siege", easing public fears and quelling dissent would be critical. And that's exactly what the 'Clergy Response Team' helped accomplish in the wake of Katrina.

Dr. Durell Tuberville serves as chaplain for the Shreveport Fire Department and the Caddo Sheriff's Office. Tuberville said of the clergy team's mission, "the primary thing that we say to anybody is, 'let's cooperate and get this thing over with and then we'll settle the differences once the crisis is over.'"

Such clergy response teams would walk a tight-rope during martial law between the demands of the government on the one side, versus the wishes of the public on the other. "In a lot of cases, these clergy would already be known in the neighborhoods in which they're helping to diffuse that situation," assured Sandy Davis. He serves as the director of the Caddo-Bossier Office of Homeland Security and Emergency Preparedness.

For the clergy team, one of the biggest tools that they will have in helping calm the public down or to obey the law is the bible itself, specifically Romans 13. Dr. Tuberville elaborated, "because the government's established by the Lord, you know. And, that's what we believe in the Christian faith. That's what's stated in the scripture."

Civil rights advocates believe the amount of public cooperation during such a time of unrest may ultimately depend on how long they expect a suspension of rights might last.

US boffins make breakthrough in anthrax vaccine

London, Aug 19: Researchers at the University of Michigan in Ann Arbor, US have made a breakthrough in anthrax vaccination, which they claim, offers better protection than the standard vaccine currently in use, which involves six injections over 18 months followed by annual boosters.

For preparing the vaccine, the researchers used an antigen derived from Bacillus anthracis, the bacterium that causes anthrax. The antigen doesn't cause sickness itself, but provokes a protective immune response.

However, instead of injecting the antigen, the researchers mixed it with a soybean oil emulsion that had been formulated into droplets only 400 nanometres in diameter.

The nanoemulsion carries the droplets into the nasal passages, where they are detected by the immune system.

"This is similar to formulations designed to penetrate the skin that were developed by the cosmetics industry. It penetrates through the pores of the mucosa. When the antigen is applied to the nose without the emulsion it causes little or no immune response," said James R. Baker Jr, an immunologist on the team that carried out the work.

To test the new vaccine, the researchers dosed mice and guinea pigs, and later exposed them to anthrax spores, either inhaled or on the skin.

The scientists found that the guinea pigs were completely protected against exposure to the skin even when the dose was a thousand times greater than the normal lethal dose.

However, the protection was not as great for inhaled anthrax. An exposure of 10 times the lethal dose killed 30 percent of the guinea pigs, and 100 times the lethal dose killed 60 percent.

According to the research team, this is about the same level of effectiveness as offered by conventional anthrax vaccines, which were developed 30 years ago.

Nevertheless, the vaccine did extend survival time by between three and five days, which, scientists believe, might allow enough time in humans for other treatments to work.

August 18, 2007

U.S. military practices genetic discrimination in denying benefits

Those medically discharged with genetic diseases are left without disability or retirement benefits. Some are fighting back.By Karen Kaplan

Eric Miller's career as an Army Ranger wasn't ended by a battlefield wound, but his DNA.

Lurking in his genes was a mutation that made him vulnerable to uncontrolled tumor growth. After suffering back pain during a tour in Afghanistan, he underwent three surgeries to remove tumors from his brain and spine that left him with numbness throughout the left side of his body.

So began his journey into a dreaded scenario of the genetic age.

Because he was born with the mutation, the Army argued it bore no responsibility for his illness and medically discharged him in 2005 without the disability benefits or health insurance he needed to fight his disease.

"The Army didn't give me anything," said Miller, 28, a seven-year veteran who is training to join the Tennessee Highway Patrol.

While genetic discrimination is banned in most cases throughout the country, it is alive and well in the U.S. military.

For more than 20 years, the armed forces have held a policy that specifically denies disability benefits to servicemen and women with congenital or hereditary conditions. The practice would be illegal in almost any other workplace.

There is one exception, instituted in 1999, that grants benefits to personnel who have served eight years.

"You could be in the military and be a six-pack-a-day smoker, and if you come down with emphysema, 'That's OK. We've got you covered,' " said Kathy Hudson, director of the Genetics and Public Policy Center at Johns Hopkins University." But if you happen to have a disease where there is an identified genetic contribution, you are screwed."

Representatives from the Pentagon declined multiple requests to discuss the policy.

A high cost

The regulation appears to have stemmed from an effort to protect the armed services from becoming a magnet for people who knew they would come down with costly genetic illnesses, according to Dr. Mark Nunes, who headed the Air Force Genetics Center's DNA diagnostic laboratory at Keesler Air Force Base in Mississippi.

The threat is almost certainly small. A 1999 military analysis estimated that about 250 service members are discharged each year for health problems involving a genetic component. Disability payments for them would amount to $1.7 million the first year and rise each year after that as more veterans join the rolls. Healthcare expenditures would have added to the tab.

"Maybe they didn't want to foot the bill for my disability," said Miller, whose rare genetic disease is called Von Hippel-Lindau syndrome. "It's saving money for them. I'm just one less soldier that they have to dish out compensation to."

But the cost for individuals medically discharged can be high. While some eventually receive benefits from Veterans Affairs or private insurers, the policy leaves Miller and others scrambling to find treatment for complex medical conditions at the same time they are reestablishing their lives as civilians without having the benefit of Tricare, the military's health insurance.

"It seems particularly draconian to say, 'Well, you're out with no benefits,' whereas another person with the same injury gets the coverage simply because we don't know there's a gene in there that's causing this," said Alex Capron, a professor who studies healthcare law, policy and ethics at USC.

The fear of genetic discrimination coincides with early efforts to decode the human genome more than 25 years ago.

It took no great insight to realize that a complete inventory of life's building blocks would not only revolutionize the practice of medicine, but also mark individuals whose genes put them at risk for myriad diseases.

Congress took action in 1996, banning genetic discrimination in group health plans, and in 2000, President Clinton signed an executive order forbidding the practice against the federal government's nearly 2 million civilian employees. Similar laws against genetic discrimination swept through 31 states.

Congress is working to extend the federal law with the Genetic Information Nondiscrimination Act, which would protect people with individual medical policies. The act has passed the House and awaits a vote in the Senate.

Even if it becomes law, it will not apply to military personnel.

The Defense Department's original policy did not consider genetics when determining whether a soldier deserved medical retirement, assuming that any disease discovered during service had been incurred in the line of duty.

There was little reason to consider genetic mutations, since few were known. But by 1986, as scientists associated more sections of DNA with particular diseases, the military declared that it was not responsible for soldiers with "congenital and hereditary" conditions.

At the urging of the National Human Genome Research Institute, the Defense Department proposed in 1999 that anyone who had served for 180 days be eligible for medical retirement, even if their health problem had a genetic component, said Barbara Fuller, assistant director for ethics at NHGRI, part of the National Institutes of Health.

But the Office of Management and Budget decided on the longer, 8-year term to conform with other military health and retirement guidelines, according to an OMB official.

Some genetic discrimination is unavoidable given the demands of military service, said Nunes, now a geneticist at Ohio State University.

"If you have achondroplasia -- if you're a dwarf -- you're not eligible for military service," he said. "If you have hereditary hearing loss, you're not eligible for military service. If you have color blindness, you're not eligible to fly an airplane. Obviously, there's genetic discrimination in the military, for good reason."

But Nunes said the armed forces' disability policy was flawed by a fundamental misunderstanding about the biology of inherited diseases.

Only in a few cases, such as Huntington's disease, does a specific mutation in a particular stretch of DNA guarantee the onset of illness.

In most cases, a faulty gene increases an individual's risk of developing a disease, but does not ensure it. Typically, an external event is necessary to trigger the onset of a medical condition.

Such was the case with an Army helicopter gunship pilot who was reassigned to desk duty after she became too pregnant to fly.

Dr. Melissa Fries, an Air Force geneticist who became involved in the case, said the pilot developed a blood clot in her leg -- a typical complication of pregnancy that is exacerbated by inactivity.

She was diagnosed with chronic thrombophlebitis, a condition that disqualified her from flying. The pilot, who declined to discuss her case, decided to retire from the Army.

As part of her medical work-up, doctors discovered she had a genetic mutation for Factor V Leiden, which is found in 5% of Caucasians and increases their risk of developing blood clots.

An Army physical evaluation board, which determines disability benefits, denied her claim because of the mutation.

Her military doctors were stunned since her thrombophlebitis was probably caused by her pregnancy and desk job. They downplayed the role of her mutation because 99% of Factor V Leiden carriers never develop blood clots.

Testing discouraged

Military doctors now discourage their patients from getting potentially life-saving genetic tests, undermining their ability to provide top-notch care.

"If someone called me up with regard to genetic testing, I had to say, 'That might not be something you want to pursue,' " Nunes said. "That's very hard to say."

In her 26 years in the Air Force, Fries said she often dissuaded women from getting tested for the BRCA1 and BRCA2 mutations that dramatically increase their risk of developing breast cancer.

She recalled counseling a 22-year-old soldier whose father had just been diagnosed with Huntington's disease. The soldier had 50-50 odds of developing the disease.

A neurologist at Walter Reed Army Medical Center ordered a genetic test for Huntington's, and it turned up positive.

"He was discharged from the military on the basis of the Huntington's disease gene even though, at that level of gene expansion, there was expected to be another 25 years before he would display any symptoms," said Fries, now director of genetics and fetal medicine at Washington Hospital Center in Washington, D.C.

For many in the military, the best course is to simply refuse all genetic tests, even though they may be needed for an accurate diagnosis, she said.

Getting genetic tests through civilian channels is not an option because it would violate the uniform code of military justice.

"You could get court-martialed if it were revealed that you had sought medical treatment or testing outside the system," Nunes said.

Most soldiers have no idea about the genetic rule, much less have a reason to challenge it. For those who choose to fight, it can be arduous process.

No one contested the policy until Marine Gunnery Sgt. Jay Platt did in 1998.

Platt had lost an eye and a testicle to Von Hippel-Lindau syndrome before doctors told him he had a malignant tumor in his left kidney and four benign tumors on his brain. He knew his 15-year Marine career was over.

"If you want to go ahead and medically retire me, I'm not going to fight it," he told his doctors.

But the Marines refused. Instead, he was medically discharged without any benefits because his genetic disease was a preexisting condition.

A discharge have would cut Platt off from Tricare, which allows members to seek care from a large network of providers, just like a civilian HMO.

"That was my biggest thing," he said. "I needed to have treatments for the rest of my life."

With the help experts from NHGRI, Platt appealed his case to an physical evaluation board. His doctors said that although the mutation predisposed him to Von Hippel-Lindau syndrome, some aspect of his service -- such as repeated exposure to the solvents used to clean weapons -- could have triggered the tumors.

Platt ultimately won his case and was granted disability payments of about $2,000 a month. He now travels the country as a motivational speaker talking about his fight against his disease.

The helicopter pilot with the Factor V Leiden mutation also appealed her case, going all the way to the Army surgeon general to win a medical retirement.

But Miller, the Army ranger, did not fare so well. Even though he had the same disease as Platt, he lost his appeal and was discharged without benefits in 2005.

He still has to monitor his slow-growing tumors and be on the lookout for new ones. But without Tricare coverage, he can't afford to see a civilian doctor close to his home in Oak Ridge, Tenn.

Instead, he travels an hour and a half to the Veterans Affairs facility in Johnson City at least twice a year. Every so often, he makes the three-hour drive to another VA facility in Lexington, Ky., to see a neurologist with expertise in his disease.

The worry never leaves him. His genes guarantee that he will never be cured.

Personal Data From Research Institute Found in Trash Bin

Boxes of file folders containing personal data as well as forms apparently connected to an Army medical research facility were found yesterday in a trash receptacle in Wheaton, Montgomery County police said.

Police said that the folders "contained personal information of individuals" and that "some of the forms appear to be related to the Walter Reed Army Institute of Research."

A resident found "numerous boxes" containing the old file folders in the 3300 block of Weeping Willow Court about 1 p.m., the police said last night in a statement.

The research institute, based in Silver Spring, describes itself as the Pentagon's largest and most diverse biomedical research laboratory.

Police said the boxes were intact, suggesting that no personal information had been compromised. Police said they were holding the files pending an investigation of how they came to be in the trash receptacle.

Police said that the research institute was notified. Officials at the institute could not be reached immediately last night.

August 17, 2007

Experimental anthrax vaccine is needle-free

WASHINGTON (Reuters) - An experimental anthrax vaccine can be squirted up the nose and might be easier to distribute than the current multishot regime, U.S. researchers reported on Friday.

The new vaccine protected guinea pigs against inhaled anthrax, considered the most dangerous form, the team at the University of Michigan Medical School and the University of Texas Medical Branch in Galveston reported.

Writing in the August issue of Infection and Immunity, Michigan's Dr. James Baker and colleagues said the secret was the adjuvant -- a compound commonly added to vaccines to make them stimulate the immune system more effectively.

The adjuvant might be used to make other vaccines more effective and more stable as well, Baker said in a telephone interview.

Their adjuvant was invented at the university and licensed to privately owned, Ann Arbor, Michigan-based NanoBio Corp. It is an oil-and-water emulsion that helps get the main vaccine ingredients into the body's immune cells.

"It is unique in that it doesn't induce an inflammatory response. What we think it does is that it actually induces delivery of the antigen," Baker said.

It apparently helps deliver the antigen -- the part of the anthrax bacteria that the immune system is supposed to recognize -- across the mucosal tissue of the nose and straight into immune cells called dendritic cells, Baker said.

Vaccines are meant to help the immune system recognize invaders such as bacteria and viruses more easily.

This one uses a single protein from the anthrax bacteria and does not cause the inflammation and irritation associated with current anthrax vaccines.

The current anthrax vaccine, given to most members of the U.S. military, is based on a 30-year-old formula and uses alum as an adjuvant. It is irritating and causes side effects and, worst of all, people need six doses and annual boosters.

LONG-TERM PROTECTION

The new vaccine protected guinea pigs after just two doses, Baker's team reported.

"We got protection after only two administrations that was good for six months after immunization," Baker said. "So it is really better than the current vaccine."

Anthrax is found naturally around the world and usually only infects animals and their handlers. It mostly causes a skin infection in people that is easily treated with antibiotics.

But the powdered spores can be inhaled and cause a hard-to-recognize infection, making anthrax an ideal biological weapon.

In October 2001, five people died out of 22 infected after someone mailed letters containing finely milled anthrax spores to New York and Washington in a crime that has never been solved.

Baker said his team must wait for U.S. government contracts to move ahead with human studies of the anthrax vaccine.

But they are using the approach for other vaccines, he said, including a hepatitis B vaccine for the developing world, funded by the Bill and Melinda Gates Foundation.

"We have got proof of concept in several other vaccines," Baker said. "By mixing antigen with the emulsion, it actually stabilizes it."

August 16, 2007

Moderator Note: Read the history (to include contract prices, names changes and name followers). Suggest for anyone that has not, read the "Op-Ed" pieces under the website: www.military-biodefensevaccines.org

Good morning, ladies and gentlemen. Good morning, my name is Gerry Scott, President of Wall Street Analyst Forum, and I will be hosting the first company at list in the Homeland Security program. The first company that is presenting with us today is an interesting one because we run an analyst conference here always [turned] occasionally with the company that right to them for biotechnology, especially pharma, the right to them for Homeland Security and this company sort of straddles both of those industry groupings.

So, I would like to introduce the first company in this segment, Emergent BioSolutions and we are welcoming those that are physically here, and welcome to the Internet attendees as well.

Emergent BioSolutions is a biopharmaceutical company dedicated to one simple mission: to protect life. They develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body's immune system to prevent or treat disease. Their biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare. Their marketed product, BioThrax Anthrax Vaccine Adsorbed, is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Their commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that resulted in significant unmet or underserved public health needs.

So without any further introduction, I would like to introduce the management of company Robert Kramer, who is here and Robert Burrows from the company.

Robert Kramer

Thank you, Gerry. As Gerry introduced, I am joined this morning by our Vice President of Investor Relations, Bob Burrows. It's my pleasure to be here with you this morning. I am going to read just a brief statement regarding the Safe Harbor statement. This presentation includes forward-looking statements, so please refer to any filings we have with the SEC.

As Gerry introduced, what we would like to talk about this morning is to give a brief overview of Emergent BioSolutions, who we are, what we do, what makes us different and why I think we are well positioned to be successful, both in this new area of biodefense as well as the more traditional commercial vaccine business in space. Also, I want to talk a little bit about our corporate operations, where we have people and what they do. A brief overview of the financials and then wrap this up with some time for Q&A at the end.

The company snapshot is such that again Emergent BioSolutions traded under ticker EBS. We first went public in November of last year. We have a market gap between $3 million and $4 million of shares outstanding right at $30 million, and our research coverage is currently provided by Cowen, HSBC, J.P. Morgan and Weisel.

As Gerry indicated, our mission and purpose is pretty simple. We protect life. We are a biopharmaceutical company that started in 1998 with the acquisition of some manufacturing operations in Lansing, Michigan as well as some FDA licensed products that I will talk about. We specialize in the development, manufacture and commercialization of immunobiotics. Those are products, primarily vaccines and therapeutics, that assist the body's immune system to prevent or treat disease. We are a different kind of company in that, first of all, we are fully integrated which is not normal for a biopharmaceutical or biotech company. We have revenue, significant revenue that is funding a number of investment opportunities that I will talk about -- both for facilities, as well as for product part of development portfolio. We had sales of our lead product BioThrax last year of approaching $150 million.

We consider ourselves a leader in the expanding biodefense market, I will talk about that in a minute, but for now we see biodefense as a growing market with the U.S. government spending and committing literally billions of dollars into the development of much needed medical counter measures for treatment and prevention against biologic attacks. Whether they be anthrax or botulinum or smallpox, plague or tularemia, those five threat agents plus others are something that the government and of all us should be concerned about. We have lead products in a number of those threat agents and categories that I'll talk about.

We have a successful track record of generating government contracts, revenue generating, as well as profit generating government contracts, and as you see we have a diversified portfolio split between our two business segments, biodefense and commercial that I have talked about. Our strategies for growth are pretty simple, again it's to pursue these two business segments, biodefense and commercial.

We focus on development not on research, so we let other companies, other organizations do the early stage research. We are very active at looking at other opportunities to invest or to acquire in terms of early stage development. And then our main focus is acquiring that technology and making sure that we advance those candidates through development to commercialization as quickly as possible, leveraging our core competencies, which are development and manufacturing.

We also apply a pretty disciplined portfolio management approach to our development portfolio, continually screening for new investments. Always being mindful about not every candidate in our development portfolio will likely be successful. So, we have 10 products in development which I’ll talk about, but we have more candidates and in the activity that we're continually looking at, our strategy is clearly to grow through acquisition as well as internal growth.

I must skip over to recent news, segment or slide 7, but briefly comment on the fact that right now we are engaged in active discussions with the US government regarding follow on contracts that I’ll talk about here shortly.

In terms of the history of the company, I want to spend a minute on page 8, which gives a chronology of the history of the company. On top we capture how the company has grown since 1998, when it was first founded and in the bottom summarizes the significant contractual relationships that we had with both the U.S. government, as well as with third parties.

As I mentioned, to start with, the company has as its origins in the Michigan Biologics Product Institute, which was a former organization that was part of the state of Michigan. The state of Michigan like several other states, Massachusetts and New York are among the two others, had actual biologic operations that were part of their community health departments.

We acquired this operation, this facility, from the State of Michigan in 1998; it has a rich history going back to the mid 1920s of development, researching, commercialization of biologic products, from agents like anthrax and botulinum and smallpox to more commercial vaccines for diphtheria, tetanus, rabies. Our focus is clearly on biodefense with this portfolio.

We've acquired the facility in '98. It took us three years to address to the satisfaction of the FDA all the compliance issues that we inherited with the acquisition. So that was a difficult time. As soon as we got that under control and well [funded] then we started making strategic acquisitions of other IP, other development products to add to our portfolio for diversification purposes, both in terms of commercial versus biodefense, as well as less reliance on the U.S. government as our only customer.

We started with Antex Biologics in June of '03 with a small development group in Gaithersburg, Maryland. We made another acquisition of a slightly larger company in June of '05 called Microscience, the UK development company, and I will talk about some of the candidates -- they are in our portfolio that evolved out of that acquisition.

In June of last year, we acquired a small development company in Germany under the name of ViVacs. They have an interesting MVA technology; we intend to evaluate its usefulness with respect to influenza products as well as other technologies. And then finally in the top we were able to go public in November of last year.

On the bottom, I am not going to go through the complete chronology, but you can see we've had a significant track record of gaining significant contracts with the U.S. government, both with DoD and HHS. It's safe to say that since 1998 we sold every dose of product of BioThrax that we've been able to manufacture to either HHS or DoD. We are capacity constraint, and I will talk in a minute about how we are solving that piece.

In addition to U.S. government, we've also made some small sales to international countries like Canada and Germany and Taiwan, and that market is a significant market that has not yet fully developed. In terms of just some numbers real quickly, you can see that since 2003 our revenues have grown from $56 million for BioThrax in '03 to almost $150 million in '06. The first half of '07 was close to $50 million.

If you look at the progression of BioThrax sales in '06 quarter-over-quarter and half-by-half, we expect the same kind of performance in '07. It's simply the nature of the contracts that we have outstanding with the government. Gross profit has been in a very similar fashion showed a steady increase from 60% in '03 to slightly 80% in '06.

I mentioned before our characterization. The company is leading in the biodefense market segment. So if you go back several years, BioSheild was passed by the Bush administration in May of '04, $6 billion dedicated to the funding for medical countermeasures against a number of threats Anthrax, botulinum, smallpox, being prime among those. The government has made a couple of significant steps since May of '04 in terms of maturing and committing to this space. One was the formation of BARDA, which is the Biological Advanced Research and Development Authority that was formed earlier this year. A lot of money was put forward in BioShield in May of '04.

The administration is currently maturing how they are managing, administering that significant amount of money with the addition of BARDA, as well as with the addition of PHEMCE, which is the Public Health Emergency Management Group within HHS who is responsible for the decision making of how HHS is spending the $6 billion.

So the key takeaway here is not just money that's available, but HHS, and the government is now putting the administration and management in oversight mechanisms in place to commit to industry that it is not just money, it's a program of system that's going to be here for a long time.

I mentioned our portfolio earlier, we have ten products in development, half in biodefense and half in commercial. Now those two are the biodefense portfolio first. Starting with BioThrax, it is our lead candidate, lead product with over 19 million doses delivered to HHS and DoD since 1998, 6 million -- over 6 million of those doses have been not just purchased, but actually used to protect military personnel.

DoD, as I talked about, has an active immunization program to vaccinate individuals who are going into high-threat areas. The safety and efficacy of BioThrax has been demonstrated time and time again. It was first licensed by the FDA in 1970, so it has been manufactured and approved by the FDA for 37 years. The safety and efficacy has been confirmed most recently by the FDA with the final order they issued in December of '05.

BioThrax, the customer base for BioThrax right now is primarily the U.S. government, split between DoD and HHS. So the Department of Defense has had an active immunization program for military personnel since the early 1990s. So they are buying our products and immunizing their military personnel with the product as opposed to HHS, who is buying our product, putting it in a Strategic National Stockpile of medical countermeasures for the protection of civilians if there is another use of anthrax as a biologic weapon.

They had purchased 10 million doses of our product so far. There is a request for proposal they issued earlier this year for as much as another 18.75 million doses. We are in active negotiations with them to finalize that contract.

The two other customers or three other customers beyond the U.S. government, I want to briefly mention. First of all, there is the emergency responder group. They are counterpart to the military who are actively exposed to the threat of anthrax are occupation such as first responders, emergency medical technicians, police and fire, who will be called in on the front-line of the use of anthrax next time. Those individuals need to be protected, need to be immunized. None of them are right now, that actually is a customer base. If you look at the full-time first responders, that’s more than a million people in United States. It's more than 5 million individuals if you include all the voluntary personnel involved in the emergency responder group -- a huge untapped market that we are aggressively pursuing.

In addition to that, I’ve mentioned the international governments, so countries such as Canada, Germany, Taiwan have purchased smaller amounts of the product, but primarily because of our capacity constraint and the fact that we are selling all we can make of DoD and HHS, we have not been able to fully capitalize on that market.

The BioThrax product is good as it is. There is always room for improvements, so we are continually investing in ongoing enhancements to BioThrax, the licensed vaccine in three areas I'll briefly touch upon. One is pre-exposure label expansion. So there I am talking about reducing the number of doses, license filed with the FDA as well as including a new route of administration to make the product even safer and hopefully more effective.

The second area is post-exposure label indication. So this is the new label indication that, as opposed to pre- or proactively immunizing at risk individuals, once someone has been exposed to anthrax, if you immunize them and give them antibiotics soon enough the combination of the vaccine and antibiotics is protective. And I'll talk in a minute about how we have the third product, which is an immune globulin product that is used once you're exposed to anthrax and it’s too late for the vaccine and antibiotics to be helpful. Then we have another product in development for those patients.

And the third area is other enhancements, such as extension of dating; right now BioThrax has a three-year label approved by the FDA and we are seeking four-year expiration dating on a product, which is a significant benefit to HHS, who is looking to stop all of the products. So rotation gets cut by a quarter, and it's a much better value proposition for them.

In addition to BioThrax, we are investing in a next-generation anthrax vaccine. We know from HHS that they are continually looking at new technologies to apply to vaccines. So our target specification for our next generation vaccine is something with a novel delivery, so take the needle out of the equation it could be a drinkable product, it could be a patch, it could be a oral delivery, something that’s more patient user-friendly rather than a needle, something where you can reduce the number of doses, could be stored at room temperature for logistical purposes right in the 2 to 8 degrees, which our current product is required to be stored at.

We have a lead candidate for this product, which is a combination of our existing product BioThrax with a new adjuvant called VaxImmune that we’re in cooperation and coordination [with fully on].

The other product that I mentioned, the anthrax immune globulin, this is a product in development in our biodefense portfolio, which is intended to be used in patients who are -- once they are exposed to anthrax and the infection is already beginning, it's too late for antibiotics, too late for vaccines, they need something that’s immediate, hard-hitting protective and that is our AIG or Anthrax immune product.

It’s manufactured taking BioThrax, the licensed vaccine, immunizing individuals, collecting their plasma and we have partnered with Talecris, an ex-Bayer company in North Carolina to fractionate our product for us in order to make this product. We are very excited about it. We filed an IND in March of this year and we will be in discussions with HHS about a development contract and a procurement contract early next year.

So just to summarize, the Anthrax franchise for us is pre-exposure with BioThrax, post-exposure but pre-symptomatic is BioThrax plus antibiotics, and symptomatic is the anthrax immune globulin product.

Real quickly, the other products in development on our biodefense portfolio clearly [stand around] both anthrax and botulinum. Through our history with Michigan, our facility, there was a long history of development of products for botulinum as well as for anthrax.

Briefly we are working on two candidates; one is the vaccine and the other is a botulinum IG product, the sister to the anthrax IG product, where again post-exposure, immediate protection. There needs to be something. All of these spaces as they wrap up the biodefence area, we think we are in lead positions with both anthrax and [BioThrax] franchises to get a significant portion of this expanding biodefense market.

There is a significant amount of money and commitment by the government. We think we are well positioned with our candidates as well as our manufacturing expertise in core competency to get our share of that funding.

Contrast that to the commercial portfolio, this portfolio of five candidates has been acquired by the company over the last three to four years, some from the Microscience acquisition in June of '05 and won the chlamydia vaccine from the acquisition of Antex in June of '03.

They are in various stages of development. I am not going go through every one in detail other than to say that our approach to product development is as a portfolio approach, we continually look and evaluate the success of these candidates through various stages of clinical trial. We look to partner with companies through third parties, either for funding or for co-development based on where we see the value of these candidates being best realized over time.

An example of that is the typhoid vaccine. It's a single-dose oral-delivered product and candidate for patients who are going to be going into areas where typhoid is prevalent. It is being partially funded by the Wellcome Trust, so we are co-developing that with them. Our hepatitis B therapeutic vaccine is a novel treatment for HBV.

Our Group B strep product is a product that we have significant interest by NIH in funding the early stages of development with. Our meningitis B product, last year we announced a licensing agreement with Sanofi, and the reason there is we think that this product has great promise. However, we think that Sanofi is in a better position to generate a long-term value of the single candidate as opposed to Emergent, so we have out-licensed. We generate some royalty payments over time. We get some milestone payments and we are best positioned to enjoy some of the economic upside of that product.

And chlamydia is an area where it is early stage, but there is a significant unmet medical need for this. This disease is a product that was acquired through the Antex acquisition in June of '03, and while it's early stage there is significant upside in this candidate.

I mean now -- quickly go to our corporate operations overview. Emergent as a company over the last five years has grown significantly from what started with the acquisition of the Michigan Biologics Products Institute in Lansing, Michigan in September of '98. We have established our headquarters in Gaithersburg, Maryland and Rockville, Maryland. We have product development sites in Gaithersburg which is the center for the biodefense product development group. We have our commercial operations for product development based in the UK, and then with the acquisition of ViVacs last year we have a small development group in Germany.

Our manufacturing operations are headquartered and based in Lansing, and we do have some additional facilities that are suitable for building out, including pilot plan operations and commercial operations in Fredrick, Maryland. We have the sales and marketing group that is reasonably small, but given our relationships with the U.S. government is necessary. So, now however within the last year we developed some satellite operations in both Germany and Singapore to support the international sale of BioThrax and other products.

Overall, we have slightly more than 500 employees. We started with the 160 in 1998.

Just a word about our manufacturing capacity since I alluded to this earlier. We are now, and have been since day one, very much capacity constraint with respect to our production capacity for BioThrax in Lansing. Because of that and as well in anticipation of growing and the importance of manufacturing in an integrated biologics company, we made a decision a year and a half ago to break ground on a new $75 million state-of-the-art biologics manufacturing facility on our campus in Lansing. So this is a 55,000-square-foot campaignable facility. So you will be capable of making multiple products. So it's not dedicated to BioThrax, not dedicated to any single product. We can make multiple products in that facility. It is in the process now of being commissioned and validated. We broke ground on it in February of 2006. The construction is complete, the equipment is installed and we are going through the very tedious process of validating and commissioning that facility today.

That will take our manufacturing capacity for BioThrax from roughly 9 million doses per year today, which we have to run the facility 24 hours a day, 7 days a week to get to over or up to 40 million doses. That 40 million can be doubled if we put in a second fermentation system and the new facility could be up to 18 million doses. So, the capacity constraint that I mentioned earlier, in terms of selling all we can make, that will soon be released.

The other manufacturing capacity we have is in our facilities in Frederick, Maryland. We have two 145,000-square-foot buildings in Frederick we bought several years ago in order to be able to respond to the manufacturing needs of our product development portfolio. We are looking at building those out first with pilot-scale facilities to support development and thence we'll evaluate whether we put commercial scale equipment in there including fill and finish capability.

A couple of snapshots on page 32 of the Lansing, we call it building 55, again 55,000-square-foot building, three floors, state-of-the-art, state-of-the-industry, really nice facility and that will clearly be the way we grow our business and through with we grow our business long term.

A quick review of the financials, I showed you some numbers early in the presentation that were BioThrax specific in terms of revenues and gross margins. But for the full company results, you can see the progression of revenue on the less than $56 million in '03 to a little more than $150 million in '06. Net income has obviously increased from $4 million to $23 million in '06. Earnings per share have shown the same type of progression.

R&D expenses -- that is obviously an important area of ours. The 10 products that are in various stages of development cost money we do so very carefully. However, still in '06, we spent just shy of $50 million investing in our development portfolio. SG&A expenses are pretty much leveled off at $45 million.

In terms of the balance sheet, the assets at the end of '06 were $238 million. Cash, both from ongoing operations as well as the proceeds of the IPO, were little more than $75 million and we had stockholders' equity of $138 million.

So, in terms of what you can expect or what you should be looking for from Emergent BioSolutions this year and until next year; first of all in the biodefense area, we have delivered all of our contractual requirements on the contracts with both DoD and HHS. We are actively involved in negotiating new contracts this year with both those important customers. Everything remains on track. We have submitted our IND for AIG [issuing check black box]. We look to complete the clinical trial on the dose reduction stage for BioThrax, in order to reduce the doses from 6 to 5 to hopefully eventually 3. We've initiated our first animal study in support of the label expansion for post-exposure protection for BioThrax and we have filed an application with the FDA to increase the dating for BioThrax from three years to fours years.

On the commercial side it's supporting the Phase II work for both the typhoid product as well as Hep B submission of the IND for the first Group B Strep combination study in combination and in coordination with NIH. And we are looking finally to do a proof of principal study with the new technology that we acquired from buybacks in June of last year in support of the third generation flu vaccine.

And so in general, just kind of take away the message -- I mean Emergent is still a recently young company. We've been in business now for almost nine years. We have grown the business essentially from a startup to a small to medium-size biopharmaceutical company. We have a very tight and clear focus on development, as well as leveraging our core competencies in manufacturing.

We have two business segments BioDefense and Commercial. The BioDefense market has stayed as some people think is significant growth opportunity for us, because of two important elements, one is our portfolio and the stage of competition with our candidates and secondly not many companies, if any are positioned as well as we are in terms of having experience in making biologic products day in and day out under an FDA compliant way, and have the expertise in terms of development and managing the transfer from development to commercial operations in a way that we can. So we think we are uniquely positioned to get our share of the $6 billion of BioShield money and other U.S. government money that is out there funding medical countermeasure development.

And then on the commercial side, we have a very strong portfolio that we continue to evaluate. We are going to grow through acquisitions. Continually look at the portfolio for ways to improving GAAP sale and again I think we are uniquely positioned to be very successful in the near-term. So I appreciate your attention and your participation this morning and I will be pleased to respond to any questions you have.

Question-and-Answer Session

Unidentified Audience Member

Why don't you say anything about the fellow that was accused of running anthrax and then to the FDA? Did you follow that at all?

Robert Kramer

Of course we followed it, I think you are referring to Zack and this Hatfield. We followed obviously with interest when it occurred and all of the follow-up investigation that occurred. My knowledge of that is very limited. It was interesting for a while. It was interesting that, not that particular issue, but the fact that whoever was behind the anthrax letters from October of '01, they really haven't determined what their root cause was or who did that. So, I think more than anything else it demonstrates how easy it is to take biologic agents like anthrax and do some pretty nasty stuff with it.

Unidentified Audience Member

Follow up question -- is it mechanically possible to trace back the manufacturer of the anthrax?

Robert Kramer

I suppose it might be possible, I mean, anthrax as you may know -- there are different types of anthrax. At our facility, the anthrax material we use to make our product is attenuated. So there is no live bacteria that goes into the manufacturing of the product.

I suppose it is possible to genetically trace that back, but it has to be very difficult. I think one of the things that was clearly learned -- look at lessons learned from October of '01. It was generally speculated that it took as many as 10,000 spores of anthrax to be lethal, that was proven not to be the case. It takes considerably fewer than 10,000 spores and as few as 100 spores. If you inhale them and keep them in your lungs it can cause death very quickly.

Another lesson learned was, just in terms of preparedness. How do we respond to that kind of event? Another lesson was the need for general education on these kinds of biologic threats and what we do – what we need to do from a medical perspective to treat that?

So a lot of work has gone in, in terms of the government preparing more details, response plans and preparations. Clearly BioShield is a part of this step, in terms of putting some money behind it. They need to complete these medical timing measures but there is still lot of work to be done. Yes.

Unidentified Audience Member

(Question Inaudible)

Robert Kramer

So we have a couple of relationships with the government from the development perspective. NIH has awarded us a small grant for the Group, B-Strep product. NIAID has given us a grant for the development of the anthrax immune globulin product. So particularly in the biodefense side since the eventual product that we come up with is going to be primarily sold to the U.S. government, our approach with biodefense is to put a specified amount of money upfront as seed investment to make sure that the proof of concept for these products is established so that when they get in line to the bidding and can be competing for a request for a proposal or a development contract they are well positioned. There is no question that they are going to be effective, but beyond that we look to the government to award development contracts and procurement contracts to pull those products through the development process to a commercial state. So again if there any questions I appreciate your participation to questions and thank you.

Operator

This presentation has now finished. Please check back shortly for the archive.

August 15, 2007

Protection Racket?

The FDA and Avandia By EVELYN PRINGLEhttp://www.counterpunch.org/pringle08162007.html

The FDA's latest campaign to protect the profits of a drug company over the safety of Americans is unprecedented, and the organizers include a gang of current and former FDA officials largely credited with turning the nation's regulatory beagle into a lapdog for Big Pharma under the Bush Administration.

FDA spokesman Douglas Arbesfeld, apparently the industry's new inside guy, kicked off the campaign by sending an e-mail to journalists which was intended to discredit Dr Steven Nissen and the Cleveland Clinic. Dr Nissen's study appeared online on May 21, 2007, in the New England Journal of Medicine and warned that GlaxoSmithKline' s diabetes drug Avandia increased the risk of heart attacks by 43% and death from cardiovascular events by possibly 64%.

The talking points for the media appear to have been formulated and agreed upon ahead of time between Arbesfeld and others (see below) because more than one story from ostensibly different sources later appeared in the media and on the internet referring to Dr Nissen with such names as "St Steven", "Patron Saint of Drug Safety" and "Saint Steven the Pure."

In his email to journalists, Mr Arbesfeld pasted portions of an article which appeared on the Heartwire website, containing umpteen critical comments about Dr Nissen and the Avandia study, as well as comments made by an anonymous blogger on the internet who said that business at the Cleveland Clinic is run similar to a Mafia TV series. The full bog states:

"Wake up pharmaceutical companies, this is a call from Dr. Nissen, if you don't hire the Cleveland Clinic for your big trials then you face the firing squad from Nissen and Company."

"The Cleveland Clinic was one of the most respected names in medicine, now they are positioning themselves as candidates to take over for a new series on HBO to replace the Soprano's " the Clinico's 'next week who should we wack ......' " Bata bing bata boon. Comment by Brian A - May 22, 2007."

However, it could just as easily be inferred that Mr Arbesfeld authored the slanderous blog and supplied it to Heartwire with the intention of quoting it later from a "reputable web site. For its part, Heartwire has since removed what it says are "unsubstantiated remarks about Dr Nissen and the Cleveland Clinic," and states: "In retrospect we regret that we published those sentences, as they do not meet the highest standards of journalistic or scientific integrity or credibility. "

The smear campaign has federal lawmakers up in arms. At a June 6, 2007 hearing before the House Oversight and Government Reform Committee, in response to questions about Mr Arbesfeld sending the e-mail under his official title of FDA spokesman, FDA Commissioner Andrew von Eschenbach told the lawmakers, "It was an inappropriate and unfortunate act on the part of an individual which has been addressed through disciplinary procedures."

Dr Nissen is none too happy about the stunt either. "I'm a pretty tough guy," he told ABC News on May 30, 2007, "but I'll tell you, having this kind of an e-mail that questions my motives, broadcast to the major journalists with whom I work and have established a reputation, is -- it's an outrage."

As for his part, Mr Arbesfeld told the Boston Globe that the email reflected his own personal views and not the FDA's. Any assertion that the email reflected his own personal views is not quite credible considering that his previous employment was always promoting the views of the industry.

A few articles in the media mentioned that Mr Arbesfeld worked for Johnson & Johnson, but his employment with public relations firm Manning Selvage & Lee was not noted. On December 16, 1999, the Healthcare Marketing & Communications Council reported that Mr Arbesfeld had joined Manning as Senior Vice President in New York.

On January 5, 2001, the firm issued a press release to announce the promotion of Mr Arbesfeld and others and referred to Manning as "one of the largest healthcare practices worldwide and has a broad array of clients including Allergan, Amgen, Eli Lilly and Company, Genentech, Hoffmann La-Roche, Kaiser Permanente, Novartis, Pharmacia and Procter & Gamble."

In reading the press release, Mr Arbesfeld's expertise with using the Internet is apparently a bi-product of his work for Manning. "In this role," it said, "Arbesfeld will help healthcare clients maximize internet-relations in the marketing and communications mix, and will expand the Practice's strategic e-product offerings."

On August 5, 2002, Arbesfeld identified himself in a Reuters article as representing none other than Glaxo, along with six other drug giants including Bristol-Myers, Aventis, J&J, AstraZeneca, Abbott Labs and Novartis, in a campaign to promote the "Together Rx" prescription drug card program for senior citizens. In 2005, the Reporters Handbook listed him as the contact person for J&J subsidiaries, Janssen Pharmaceutica, Ortho-McNeil Pharmaceutical and Ortho Biotech Products.

Less than a week after Mr Arbesfeld's hatchet job on Dr Nissen, ex-FDA Deputy Commissioner Dr Scott Gottlieb planted an editorial in the May 29, 2007, Wall Street Journal entitled, "Journalist Malpractice, " accusing the New England Medical Journal of intentionally publishing the Nissen study to make the FDA look impotent. "The publication was timed," he wrote, "to get ahead of the Food and Drug Administration' s more careful evaluation of the same issues."

"The journal seemed bent on beating the FDA to the punch," Dr Gottlieb claimed.

"The goal?" he said, "Painting the FDA as impotent, in order to argue for legislation winding through Congress that would increase regulatory hurdles for drug approvals."

The only problem with the Nissen-NEJM conspiracy theory is that the issue under investigation in Congress right now is why the FDA did not warn the public about Avandia heart risks six months before the Nissen study was ever published.

In the end, when it comes to "Journalistic Malpractice, " the larger question would seem to be how was it that so many industry shills were able to get the major media outlets and medical journals to immediately publish commentaries and editorials attacking the NEJM and the Nissen research with headlines splashing all over the internet.

In his editorial, Dr Gottlieb notes that there are "questions" whether Avandia is associated with heart risks, but says they are "so far unsupported by more rigorous, randomized studies and extensive review by the FDA and other authorities around the world."

"When it comes to the issue du jour, drug safety," he wrote, "no description of medical research in a medical journal comes close to the detail level or scrutiny imposed by the FDA on study results before approval."

Assuming this is true, the problem is that the industry insiders running the FDA refuse to act on the advice of the agency's top scientists with first hand access to the underlying data. In a July 26, 2007 speech on the Senate floor, Senator Charles Grassley (R-Iowa), of the Senate Finance Committee, said that, in the case of Avandia, "Not only did the FDA disregard the concerns and recommendations from the office responsible for post-marketing surveillance, but I have found that it also attempted to suppress scientific dissent."

In the past two months, he told his fellow senators, "I've had to write to the FDA regarding the suppression of dissent from not one but two FDA officials involved in the review of Avandia."

The Heartwire website conveniently echoed Dr Gottlieb's sentiments by featuring portions of a May 23, 2007, unsigned editorial from the medical journal The Lancet, which claimed that the verdict on Avandia should await the results of a Glaxo sponsored trial called RECORD, not due out until 2009.

"Taken together," the editorial said of Dr Nissen's findings, "these results, although based on very small numbers of events, certainly raise a signal of concern and indicate the need for more reliable information about rosiglitazone' s safety."

"But the FDA, physicians, and patients can reasonably await the results of RECORD, a phase 3 trial designed specifically to study cardiovascular outcomes," it said.

"Until the results of RECORD are in," the Lancet noted, "it would be premature to overinterpret a meta-analysis that the authors and NEJM editorialists all acknowledge contains important weaknesses."

The problem with waiting two years for the results of the RECORD trial is that FDA scientist Dr David Graham reviewed the results of this study thus far and told an FDA advisory panel that the study design is so flawed that the results should not be considered in any risk benefit analysis of Avandia now, or in 2009.

In fact, Dr Graham says the RECORD study is so useless that it is probably unethical to allow it to continue because no possible benefit can be achieved by allowing it to go on and that Avandia should be pulled off the market now because thousands of patients are being injured each month by using the drug.

At the end of his editorial, Dr Gottlieb lists himself as a physician and a resident fellow at the American Enterprise Institute, as well as former Deputy Commissioner of the FDA from 2005 to 2007. However, back on August 24, 2005, the Seattle Times provided a much better picture of his background and highlighted the oddity of the FDA hiring him in the first place in light of his solid alliance with the industry. "Only a month ago," the article states, "Dr Scott Gottlieb was a Wall Street insider, promoting hot biotech stocks to investors."

At the time, the Times noted, "Now Gottlieb holds the No. 2 job at the federal agency that approves new drugs, oversees their safety and affects the fortunes of companies he once touted."

"Now, as one of three deputy commissioners, " the article said, "Gottlieb will help oversee such major policies as the FDA's fast-track approval process for drug and biotech products, a priority for many Wall Street funds and the pharmaceutical industry."

The Times also noted that a half-dozen current and former FDA officials said they did not know of anyone else from Wall Street ever moving directly into such a high-level job at the agency.

A couple months later, the November 12, 2005, Boston Globe reported that Dr Gottlieb could not participate in formulating the nation's defense plan against the avian flu due to conflicts of interest. He "was recused from key parts of the planning effort because his past consulting work for Manning Selvage & Lee involved companies whose products would be used to combat a flu pandemic," it said. Yes, the very same Manning Selvage & Lee at which Arbesfeld held the Senior Vice President position. Does anyone smell a rat (or several)?

The article pointed out that Dr Gottlieb's former clients included Roche, the manufacturer of Tamiflu, and Sanofi-Aventis, the parent company of the nation's sole flu vaccine maker.

According to the Globe, Manning paid Gottlieb a $12,500 monthly retainer for nine months for projects that included eight companies, and he was also paid $9,000 for private consulting work for VanGen Inc, a firm that won a $878-million contract to supply the US government with 75 million doses of anthrax vaccine.

Dr Nissen and Dr Gottlieb's disputes are not new. In fact, on August 2, 2006, they participated in a debate on the topic: "Government Science Panels: Fair and Balanced?" sponsored by the Center for Science in the Public Interest, and reported on by Russell Mokhiber and Robert Weissman in Common Dreams.

Likewise, lawmakers have mentioned in their communications with the FDA that they found it "troubling" that Mr Arbesfeld might be trying to settle old scores with Dr Nissen because they were on opposite sides regarding the approval of the heart failure drug Natrecor.

Much to his credit, Dr Nissen openly communicated his objections to the industry's infiltration of the FDA. While sitting right next to Dr Gottlieb, he candidly described the conflicts of interest, which he stated were "evident at the highest levels of the FDA."

"For years," he said of FDA leadership, "we had an interim FDA Commissioner, Lester Crawford, who shortly after confirmation, abruptly resigns, apparently because he and his wife owned stock in regulated companies."

"Then the administration appointed Andrew von Eschenbach as interim commissioner creating another conflict," he said. "In his role as director of the National Cancer Institute, von Eschenbach must seek FDA approval for human testing or approval of new cancer drugs, an obvious conflict," he noted.

"He came to this job with no regulatory experience, directly from Wall Street, where he served as a biotech analyst and stock promoter," Dr Nissen told the audience.

Dr Gottlieb's response to Dr Nissen's comments was, in essence, that he would not dignify the comments with a response.

Firms with which Dr Gottlieb was involved prior to his gig at the FDA, according to the Globe, also include the Inamed Corp, one of two companies that were seeking to return silicone gel implants to the market and on November 17, 2006, the FDA announced that it would lift restrictions on the sale of the implants.

When Dr Gottlieb left the FDA, he headed right back to greener pastures with the drug giant Novartis. The press release to announce his hiring read: "Bench International Places Eminent Regulatory Advisor Scott Gottlieb, M.D., as Senior Counsel to Novartis."

"Under an exclusive consulting agreement," the release stated, "Scott Gottlieb, M.D., will provide advisory services to Novartis on matters of global regulatory policy and strategy."Two more members of FDA,s alumni, Peter Pitts and Robert Goldberg took another swipe at Dr. Nissen in a June 6, 2007 commentary in the Washington Times, using the same talking points as the anonymous blogger, likewise referring to Dr. Nissen as a "self-appointed and media-anointed Patron Saint of Drug Safety and "Saint Steven the Pure.

For much of the childish commentary, they poke fun at Dr Nissen because he acknowledged in the NEJM that he consults for many drug companies but said he "requires them to donate all honoraria or consulting fees directly to charity so that he receives neither income nor a tax deduction."

At the end of the commentary, Mr Pitts says he is a former FDA associate commissioner, and both men list their affiliation with the Center for Medicine in the Public Interest; but as usual, that listing really does not give credit where credit is due.

On its web site, the Center describes itself as "a non-partisan, non-profit educational charity," and Mr Pitts is indeed listed as President, but his bio also says he is the Senior Vice President for Global Health Affairs at none other than Manning, Selvege & Lee.

The Manning firm apparently fills two important roles. It's a breeding ground for industry moles preparing to enter "public service" and serves as an employment hub for industry shills once they finish their on average 2- to 3-year stint inside the Bush Administration.

In his CMPI bio, Mr Pitts describes his duties as the FDA's Associate Commissioner from 2002 to 2004 as serving as the agency's "Chief Messaging Officer."

On June 7, 2007, Mr Pitts had this to say in defense of fellow hit-man Mr Arbesfeld on the Pharmalot web site: "I know Doug Arbesfeld and he is a guy devoted to advancing the public health."

According to Mr Pitts, in sending the derogatory e-mail about Dr Nissen to journalists, Mr Arbesfeld was just standing up for the FDA and that people should know about the sacrifice he made by accepting a job in government.

"He is also a guy," Mr Pitts says, "who took a pretty significant pay cut to put in some time in public service."

Some would no doubt argue that it's difficult to imagine that Mr Arbesfeld will end up in the poor house as a result of serving as the top industry mole inside the FDA.

Mr Pitts' sidekick, Mr Goldberg, is indeed listed as the vice president of CMPI, but Mr Goldberg's bio also says he used to be Director of the Manhattan Institute's Center for Medical Progress and Chairman of its 21st Century FDA Task Force.

In fact, a review of the CMPI web site turned up a whole nest of ex-moles who served the industry in one capacity or another in the Bush Administration' s FDA. For instance, Daniel Troy, the former FDA Chief Counsel, also known as the "Godfather of Preemption," sits on this "charity's" Advisory Board.

Troy,s bio points out that he "played a principal role in FDA,s generally successful assertion of preemption in selected product liability cases."

This "assertion of preemption" says that, as long as the FDA has approved a drug and its label, private citizens in state courts cannot sue the drug company for failing to warn about a product's serious health risks, even in cases where it can be shown that the company concealed studies that revealed the risk from the public and the FDA.

Now that he's switched back to private practice, Mr Troy's CMPI bio says he currently specializes in constitutional and appellate litigation, as well as strategic counseling with "particular focus" on what else - clients regulated by the FDA.

The Advisory Board also includes, Tomas Philipson, whose bio says he served as the Senior Economic Advisor to the commissioner of FDA during 2003 and 2004 and as the Senior Economic Advisor to the administrator of the Centers for Medicare and Medicaid Services in 2004 and 2005.

That would mean that Mr Philipson served Mark McClellan, and they are now apparently joined at the hip because, as part of a program called "Patient-Centric and Prospective Medicine," CMPI says it has created the Patient-Centric Health Forum and that Mr McClellan, "former Medicare administrator and FDA commissioner, will chair the group."

So, it would appear that anyone looking for the retirement home for industry hit men who served in the Bush Administration' s FDA can find it right in the middle of cyberspace on the CMPI web site.

August 14, 2007

Source Disclosure Ordered in Anthrax Suit

Five reporters must reveal their government sources for stories they wrote about Steven J. Hatfill and investigators' suspicions that the former Army scientist was behind the deadly anthrax attacks of 2001, a federal judge ruled yesterday.

The decision from U.S. District Judge Reggie B. Walton is yet another blow to the news industry as it seeks to shield anonymous sources who provide critical information -- especially on the secret inner workings of government.

"The names of the sources are central to Dr. Hatfill's case," Walton wrote in a 31-page opinion.

The ruling is a victory for Hatfill, a bioterrorism expert who has argued in a civil suit that the government violated his privacy rights and ruined his chances at a job by unfairly leaking information about the probe. He has not been charged in the attacks that killed five people and sickened 17 others, and he has denied wrongdoing.

Hatfill's suit, filed in 2003, accuses the government of waging a "coordinated smear campaign." To succeed, Hatfill and his attorneys have been seeking the identities of FBI and Justice Department officials who disclosed disparaging information about him to the media.

In lengthy depositions in the case, reporters have identified 100 instances when Justice or FBI sources provided them with information about the investigation of Hatfill and the techniques used to probe his possible role in anthrax-laced mailings. But the reporters have refused to name the individuals.

The decision means that five journalists -- Allan Lengel of the Washington Post; Michael Isikoff and Daniel Klaidman, both of Newsweek; Toni Locy, formerly of USA Today; and James Stewart of CBS News -- are under instruction from the court to answer specific questions about who provided them with information about the investigation's focus on Hatfill.

The judge turned down a companion bid by Hatfill to subpoena testimony from corporate representatives and records from ABC, The Washington Post, Newsweek, CBS, the Associated Press, the Baltimore Sun and the New York Times. He said he would reconsider the ruling on the media companies if the reporters continue to refuse to reveal their sources.

In 2002, then-Attorney General John D. Ashcroft called Hatfill, who had formerly worked at the Army's infectious diseases lab in Fort Detrick in Frederick County, a "person of interest" in the anthrax case. Authorities have not made any arrests in the investigation.

Walton declined to recognize the existence of a federal common law privilege for reporters. Also, the judge broadly defined the kinds of information that, if released, would violate the Privacy Act to include almost anything specific to Hatfill and suspicions about him. Media lawyers argued the Privacy Act was not intended to apply to the information they reported about Hatfill.

Walton said Hatfill's search for government leakers is "strikingly similar" to the civil suit filed by Wen Ho Lee, a nuclear scientist who became the subject of a flurry of media stories identifying him as a chief suspect in a nuclear-secrets spy case. Those stories also relied on anonymous sources. Lee was never charged with espionage; he pleaded guilty to mishandling computer files. He sued the Justice Department, and reporters were facing a court order to reveal sources. But the case ended last year when the news companies and the government paid Lee a $1.6 million settlement.

Lucy Dalglish of the Reporters Committee for Freedom of the Press said the Hatfill case probably will have "horrifying" repercussions on the ability to report on the government's handling of public health crises.

"It may be that Mr. Hatfill was done wrong by the federal government," Dalglish said. "But these reporters were just trying to inform the public about whether the government had a clue about what was happening."

Washington Post Deputy Counsel Eric Lieberman said it would not be appropriate to comment on the ruling at this point in the proceedings.

Soldiers from elite unit have submitted a petition to Israel’s High Court of Justice, demanding that the army accept responsibility for treating the illnesses allegedly resulting from an experimental anthrax vaccine, and that it reveal the secret experiment’s decision-

making process and supervision mechanism.

Petitioners suffer from skin and respiratory complaints, among other ailments.

In the course of an 8-year experiment code-named Omer 2, which began in 1998, 25% of the soldiers were injected with American-made vaccine and 75% with a previously untested Israeli vaccine. Soldiers in both groups suffered persistent symptoms.

Public health laws require that physicians may not conduct experiments on persons subject to their authority except under the supervision of the Helsinki Committee and the Health Ministry’s pharmaceutical division. Omer 2 is said to have violated both conditions. (Haaretz 2/27/07).

U.S. research on anthrax vaccine was criticized in oral testimony before the House Veterans’ Affairs Committee, Subcommittee on Health,

by Meryl Nass, M.D., on July 26. She stated that research on Gulf War syndrome and anthrax vaccine was unusable because the wrong questions were asked; data were withheld; sample sizes were inadequate; and control groups contained exposed subjects while exposed groups contained unexposed subjects.

Student treated after anthrax spill in Mississippi lab

Aug 14, 2007 (CIDRAP News) – A graduate student working in a biosafety level 3 (BSL-3) laboratory at the University of Mississippi Medical Center (UMMC) was treated for possible anthrax exposure following a laboratory accident Aug 11—two days after a US House committee announced plans to hold hearings on biodefense lab safety.

According to a statement released to journalists by the UMMC press office in Jackson, Miss., the student inoculated a flask of medium with anthrax cells and then tried to place it in a shaker, at which point it broke.

The student immediately followed the anthrax lab's biosafety plan, which includes actions to protect personnel and ensure that pathogens do not escape the lab, the press release said. Officials at UMMC and the US Centers for Disease Control and Prevention were notified about the incident.

"At no time was there a risk of infection to anyone outside the lab, which is specially designed to contain biohazards," the UMMC statement said, adding that the student was allowed to return home after precautionary treatment.

In other biodefense lab news, the US House Committee on Energy and Commerce recently announced plans for a hearing in early October to examine the risks associated with the nation's growing number of BSL-3 and BSL-4 laboratories, which handle dangerous microbial agents.

"It appears that there has been a surge in construction of biosafety labs over the past several years, which have been financed, at least in part, with federal funds," said committee chairman Rep. John D. Dingell, D-Mich., in an Aug 9 press release from the committee. "Yet little information is available about the number of labs being operated in the US and whether they are safely run."

The committee statement pointed to the role of a lab in the recent outbreak of foot-and-mouth disease (FMD) in Britain, as well as a recent accident at Texas A & M University involving Q fever.

A preliminary report from the British government last week said the FMD outbreak, discovered recently near London, was probably caused by a virus that leaked from a Surrey laboratory that is shared by a government-funded institute and a company that makes FMD vaccine.

In late June the CDC suspended work in a Texas A&M biodefense lab while it investigated reports from the Sunshine Project, a watchdog group, that lab workers had been infected with the category B bioterrorism agents Brucella and Coxiella burnetti.

Rep Bart Stupak, D-Mich., chairman of the House Subcommittee on Oversight and Investigations, said in the statement that legislators need to explore whether an increasing number of high-security labs increases the chance of a release of deadly disease. "We want to know the answer or whether anyone in the Administration has even seriously considered the question," he said.

Witnesses at the hearing will include officials from the Government Accountability Office (GAO) and others to be announced later, the committee said.

See also:

Aug 9 US House Committee on Energy and Commerce press releasehttp://energycommerce.house.gov/Press_110/110nr57.shtml